Instructions for use. Eglonil ® (Eglonil ®) Marketing authorization holder

Instructions for use

Eglonil instructions for use

Dosage form

Hard gelatin capsules No. 4, consisting of an opaque body and cap, white or white with a yellowish-grayish tint. The contents of the capsules are a homogeneous white to yellowish powder.

A tint of color. The formation of lumps that crumble when pressed is allowed.

Compound

1 capsule contains: active ingredient: sulpiride -50 mg;

Excipients: lactose monohydrate - 66.92 mg, methylcellulose - 0.58 mg, talc - 1.30 mg, magnesium stearate - 1.20 mg. Capsule composition: gelatin - 98%, titanium dioxide (E 171) - 2%.

Pharmacodynamics

Sulpiride is an atypical antipsychotic from the group of substituted benzamides that blocks dopaminergic nerve transmission in the brain (sulpiride blocks mainly

Dopaminergic receptors of the limbic system, having little effect on those in the neostriatal system). Its neuroleptic effect is associated with antidopaminergic action. In addition, sulpiride has a CNS activating effect due to the dopamine mimetic effect. Therefore, sulpiride has a moderate antipsychotic activity in combination with a stimulating and thymoanaleptic (antidepressant) effect. The antipsychotic effect of sulpiride is manifested in doses of more than 600 mg per day, in doses up to 600 mg per day, stimulating and antidepressant effects predominate. Sulpiride has no significant effect on adrenergic,

Cholinergic, serotonin, histamine and CABA receptors. Sulpiride stimulates the secretion of prolactin and has a central antiemetic effect (inhibition of the vomiting center) due to the blockade of dopamine D2 receptors in the trigger zone of the vomiting center.

Pharmacokinetics

Suction

When ingesting one capsule of 50 mg, the maximum concentration of sulpiride in plasma is reached after 3-6 hours and is 0.25 mg / l.

The bioavailability of sulpiride when taken orally is 25-35% and is characterized by significant individual variability. The pharmacokinetics of sulpiride remains linear in the dose range from 50 to 300 mg.

Distribution

Sulpiride is rapidly distributed into tissues: the volume of distribution in the equilibrium state is 0.94 l / kg.

Communication with plasma proteins - approximately 40%.

A small amount of sulpiride appears in breast milk and passes through the placental barrier.

Metabolism

In the human body, sulpiride is only slightly metabolized.

breeding

Sulpiride is excreted mainly by the kidneys unchanged by glomerular filtration. The total clearance is 126 ml / min. The half-life of the drug from plasma is 7 hours.

Side effects

Classification of adverse reactions (AR) according to the frequency of development, according to the recommendations of the World Health Organization: very often (> 10%); often (>1% and<10 %); нечасто (>0.1% and<1 %); редко (>0.01% and<0,1 %); очень редко (<0,01 %); частота неизвестна (на основании имеющихся данных невозможно оценить частоту развития НР). НР, развивающиеся в результате приема сульпирида, подобны НР, вызываемым другими нейролептиками, но частота их развития, в основном, меньше.

Heart disorders

Rarely: ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia.

Frequency not known: QT prolongation, torsades de pointes, cardiac arrest

Hearts, sudden death.

Vascular disorders

Uncommon: orthostatic hypotension.

Frequency unknown: venous thromboembolic complications, including pulmonary thromboembolism

Arteries and deep vein thrombosis, sometimes fatal; increased blood pressure (see section "Special Instructions").

Endocrine Disorders

Often: hyperprolactinemia.

General disorders

Often: weight gain.

Liver and biliary tract disorders

Often: increased activity of "liver" enzymes.

Nervous System Disorders

Often: sedation or drowsiness, extrapyramidal disorders (these symptoms are usually reversible after the appointment of antiparkinsonian drugs), parkinsonism, tremor, akathisia.

Uncommon: muscle hypertonicity, dyskinesia, muscular dystonia.

Rare: oculogyric crisis.

The frequency is unknown: neuroleptic malignant syndrome, hypokinesia, tardive dyskinesia (as with all antipsychotics, after their use for more than 3 months; while taking antiparkinsonian drugs is ineffective or may provoke an increase in symptoms), convulsions.

Violations of the genital organs and mammary glands

Often: soreness of the mammary glands, galactorrhea.

Uncommon: breast enlargement, amenorrhea, orgasmic dysfunction (orgasmic disorders), erectile dysfunction;

Frequency unknown: gynecomastia.

Skin and subcutaneous tissue disorders

Often: macular-papular rash.

Blood and lymphatic system disorders

Uncommon: leukopenia.

Frequency unknown: neutropenia, agranulocytosis.

Pregnancy, postpartum and perinatal conditions

Frequency unknown: extrapyramidal symptoms, "withdrawal syndrome" in newborns (see section

"Pregnancy and the period of breastfeeding").

Immune System Disorders

Frequency unknown: anaphylactic reactions: urticaria, shortness of breath, excessive lowering of blood pressure, anaphylactic shock.

Mental disorders

Often: insomnia.

Frequency unknown: confusion.

Gastrointestinal disorders

Uncommon: hypersalivation.

Musculoskeletal and connective tissue disorders

Frequency unknown: torticollis, lockjaw.

Metabolic and nutritional disorders:

Frequency unknown: hyponatremia, syndrome of inappropriate secretion of antidiuretic hormone.

Selling Features

prescription

Special conditions

Malignant neuroleptic syndrome

Malignant neuroleptic syndrome, which is a potentially fatal complication, and the occurrence of which is possible with the use of any antipsychotics, is characterized by pallor, hyperthermia, muscle rigidity, dysfunction of the autonomic nervous system, impaired consciousness. Signs of autonomic nervous system dysfunction, such as increased sweating and lability in blood pressure and pulse, may precede the onset of hyperthermia and are early warning signs. In the event of an unexplained increase in body temperature, treatment with sulpiride should be discontinued. The cause of the development of neuroleptic malignant syndrome remains unclear. It is assumed that blockade of dopamine receptors in the striatum and hypothalamus plays a role in its mechanism; congenital predisposition (idiosyncrasy) is also not excluded. The development of the syndrome may be facilitated by intercurrent infection, dehydration, or organic brain damage.

QT prolongation

Sulpiride may cause prolongation of the QT interval. It is known that this effect increases the risk of developing severe ventricular arrhythmias, such as torsades de pointes (see section "Side effect").

Before using the drug, if the patient's condition allows, it is necessary to exclude the presence of factors predisposing to the development of these severe arrhythmias (bradycardia less than 55 beats per minute, hypokalemia, hypomagnesemia, slowing intraventricular conduction and congenital prolonged QT interval or prolongation of the QT interval when using other drugs, prolonging the QT interval) (see sections "With caution", "Side effect").

In patients with the above risk factors, if necessary, the appointment of sulpiride should be used with caution.

Hypokalemia and hypomagnesemia should be corrected before starting the drug; in addition, medical supervision and regular monitoring of blood electrolytes and ECG should be provided.

Except in cases of urgent intervention, patients who require treatment with antipsychotics are recommended to evaluate the condition and monitor the ECG.

Extrapyramidal syndrome

With extrapyramidal syndrome caused by neuroleptics, m-anticholinergic drugs (and not dopamine receptor agonists) should be prescribed (see section "Interaction with other drugs").

In randomized clinical trials compared with placebo, some atypical antipsychotics in elderly patients with dementia, a three-fold increase in the risk of developing cerebrovascular complications was observed. The mechanism of this risk is unknown. An increase in this risk with other antipsychotics or in other patient populations cannot be ruled out, so sulpiride should be used with caution in patients with risk factors for stroke.

Elderly patients with dementia

In elderly patients with psychosis associated with dementia, an increased risk of death was observed during treatment with antipsychotic drugs. An analysis of 17 placebo-controlled trials (average duration over 10 weeks) showed that the majority of patients treated with atypical antipsychotics had a 1.6-1.7 times greater risk of death than patients treated with placebo. In a 10-week placebo-controlled study, the incidence of deaths when taking atypical antipsychotics in such patients was 4.5%, and when taking placebo - 2.6%. Although the causes of death in clinical trials with atypical antipsychotics varied, most causes of death were either cardiovascular (eg, cardiac

failure, sudden death), or infectious (eg, pneumonia) in nature.

Observational studies have confirmed that, like treatment with atypical antipsychotics, treatment with conventional antipsychotics can also increase

Mortality. The extent to which the increase in mortality may be due to the antipsychotic drug rather than some patient characteristics is not clear.

Venous thromboembolic complications

Cases of venous thromboembolic events have been observed with the use of antipsychotic drugs.

Complications, sometimes fatal. Therefore, sulpiride should be used with caution in patients with risk factors for the development of venous thromboembolic complications (see sections "With caution", "Side effect").

Mammary cancer

Sulpiride can increase the concentration of prolactin in the blood plasma. Therefore, when using sulpiride in patients with a history (including family history) of breast cancer, caution should be exercised (see section "With caution"). Such patients should be closely monitored.

Patients with epilepsy

Due to the fact that antipsychotics can lower the epileptogenic threshold, when prescribing sulpiride to patients with epilepsy, the latter should be under strict medical supervision.

Patients with Parkinson's disease taking dopamine receptor agonists

Except in exceptional cases, the drug Eglonil® should not be used in patients with Parkinson's disease. If there is an urgent need for antipsychotic treatment in patients with Parkinson's disease taking dopamine receptor agonists, a gradual reduction in doses of the latter should be carried out until complete withdrawal (abrupt withdrawal of dopamine receptor agonists may increase the patient's risk of neuroleptic malignant syndrome) (see sections "With caution", "Interaction with other drugs").

Patients with impaired renal function

Reduced doses should be used (see section "Method of application and doses").

Patients with diabetes mellitus or with risk factors for developing diabetes

Since the development of hyperglycemia in patients taking atypical antipsychotics has been reported, patients with an established diagnosis of diabetes mellitus or with risk factors for its development who are prescribed treatment with sulpiride should be monitored

The concentration of glucose in the blood.

Ethanol consumption

The use of alcoholic beverages containing ethanol or the use of drugs,

Leukopenia, neutropenia and agranulocytosis

Leukopenia, neutropenia and agranulocytosis were observed during therapy with neuroleptics, including Eglonil®. The development of unexplained infections or an increase in body temperature may be signs of blood disorders, which require immediate hematological studies.

Use in children

In connection with the influence of sulpiride on cognitive processes in children, it is necessary to monitor the ability to learn annually. It is necessary to adjust the dose regularly, taking into account the clinical condition of the child.

Influence on the ability to drive transport. cf. and fur.:

During treatment with Eglonil®, driving and

Engaging in other potentially hazardous activities that require attention and

The speed of psychomotor reactions (since when used even in recommended doses, the drug

May cause sedation).

Indications

Anxiety conditions in adults (short-term symptomatic treatment, when conventional methods of treatment are ineffective)

Severe behavioral disorders (agitation, self-mutilation, stereotypy) in children older than 6 years, especially those with autism syndromes.

Contraindications

Hypersensitivity to sulpiride or excipients of the drug.

Prolactin-dependent tumors (pituitary prolactinomas and breast cancer).

Hyperprolactinemia.

Pheochromocytoma.

Acute porphyria.

Children's age up to 6 years (for this dosage form).

Acute intoxication with alcohol (ethanol), sleeping pills, narcotic analgesics.

breastfeeding period.

Congenital galactosemia, glucose / galactose malabsorption syndrome or lactase deficiency (due to the presence of lactose in the preparation).

Simultaneous administration of levodopa (see section "Interaction with other drugs").

Concomitant therapy with dopamine receptor agonists (cabergoline, quinagolide, ropinirole, rotigotine) (see section "Interaction with other drugs").

Carefully:

In patients with a predisposition to the development of cardiac arrhythmias, due to the fact that sulpiride can cause a prolongation of the QT interval and increase the risk of developing severe ventricular arrhythmias, such as the development of ventricular tachycardia of the "pirouette" type:

With bradycardia less than 55 beats per minute;

With electrolyte disturbances, in particular, with hypokalemia;

With congenital prolongation of the QT interval;

Simultaneously receiving drugs that can cause severe bradycardia (less than 55

beats per minute); hypokalemia; slowing of intracardiac conduction or

Prolongation of the QT interval (see sections "Interaction with other drugs", "Special instructions").

In patients with a history of neuroleptic malignant syndrome (see sections "Side Effects", "Special Instructions").

In elderly patients (increased risk of sedation, orthostatic hypotension, extrapyramidal disorders).

Aggressive behavior or agitation with impulsivity (may require simultaneous use of sedatives).

In elderly patients with dementia (see section "Special Instructions").

In patients with risk factors for stroke (see section "Special Instructions").

In patients with Parkinson's disease (see section "Special Instructions"). thromboembolic complications (see section "Special Instructions").

In diabetes mellitus and in the presence of risk factors for the development of diabetes mellitus (risk of hyperglycemia, blood glucose control is required).

Pregnancy (limited experience) (see Pregnancy and lactation section).

With renal insufficiency (correction of the dosing regimen is required, see the section "Method of administration and doses").

With a history of epilepsy or convulsive seizures (risk of lowering the threshold for convulsive readiness) (see section "Special Instructions").

With the simultaneous use of drugs containing ethanol (see section "Interaction with other drugs").

In patients with a history of indications of glaucoma, intestinal obstruction, congenital

Stenosis of the digestive tract, urinary retention or prostatic hyperplasia (since the drug has m-anticholinergic properties).

In patients (especially elderly patients) with arterial hypertension due to the risk

Development of a hypertensive crisis (patients should be under medical supervision).

When used in children, caution should be exercised, since the effectiveness and safety

Sulpiride in this category of patients have not been studied enough (see section "Special Instructions").

Pregnancy and lactation:

Animal experiments and limited experience with the use of sulpiride in pregnant women have not shown a teratogenic effect. Due to the limited data on the use of the drug by pregnant women, the use of sulpiride during pregnancy is not recommended. If sulpiride is nevertheless used during pregnancy, newborns should be monitored taking into account the safety profile of sulpiride (see "Side Effects").

In humans, sulpiride passes into breast milk. Therefore, breastfeeding during treatment with sulpiride is not recommended.

drug interaction

Contraindicated combinations

With levodopa

Mutual antagonism of the effects of levodopa and antipsychotics.

With dopamine receptor agonists (cabergoline, quinagolide, ropinirole, rotigotine) Mutual antagonism between dopamine receptor agonists and antipsychotics. Not recommended combinations

With ethanol

Ethanol enhances the sedative effect of neuroleptics. Alcoholic beverages and medicines containing ethanol should be avoided.

With drugs that can prolong the QT interval or cause the development of ventricular tachycardia of the "pirouette" type:

Drugs that cause bradycardia: beta-blockers; blockers of "slow" calcium channels (verapamil, diltiazem) that reduce the heart rate; clonidine, guanfagen; cardiac glycosides;

Drugs that cause hypokalemia: diuretics that reduce the concentration of potassium in the blood;

Laxatives that stimulate intestinal motility; amphotericin B for intravenous use; glucocorticosteroids; tetracosactide (before taking sulpiride, hypokalemia must be corrected);

Class 1A antiarrhythmic drugs such as quinidine, disopyramide;

Class III antiarrhythmic drugs such as amiodarone, sotalol;

other drugs such as pimozide; sultopride; haloperidol; thioridazine;

Methadone; antidepressants, imipramine derivatives; lithium preparations; bepridil; cisapride;

Intravenous erythromycin; intravenously administered vincamine; halofantrine; pentamidine; sparfloxacin;

Selective serotonin reuptake inhibitors (citalopram, escitalopram).

If patients cannot avoid the simultaneous use of these drugs with sulpiride, then for

Patients should undergo careful clinical, laboratory (blood electrolyte monitoring) and electrocardiographic monitoring.

Interactions to be taken into account

With antihypertensive drugs

Additive hypotensive effect, increased risk of orthostatic hypotension.

With drugs that depress the function of the central nervous system: narcotic analgesics; blockers H1-

Histamine receptors with a sedative effect; barbiturates; benzodiazepines and other anxiolytics; clonidine and other centrally acting antihypertensive drugs.

Perhaps a pronounced increase in the inhibitory effect of the central nervous system and a decrease in the psychomotor reaction.

With antacids and sucralfate

With simultaneous use, the absorption of sulpiride decreases. Therefore, the combined use of sulpiride and antacids or sucralfate requires at least a two-hour break between their intake.

With lithium preparations

The risk of extrapyramidal side reactions increases. At the first symptoms

Neurotoxicity should stop taking both drugs.

SANOFI-AVENTIS SYNTHELABO GROUPE Sanofi Winthrop Industry Sanofi Winthrop Industry

Country of origin

France

Product group

Nervous system

Antipsychotic drug (neuroleptic)

Release form

• 12 - blisters (1) - packs of cardboard. 2 ml - ampoules (6) - contour plastic packaging (1) - cardboard packs. pack 30 capsules

Description of the dosage form

• Capsules Solution for intramuscular injection is clear, colorless or almost colorless, odorless or almost odorless. Pills

pharmachologic effect

Antipsychotic. Blocks dopamine receptors. In small doses, acting at the level of central dopaminergic receptors, it has a disinhibitory effect. In doses above 600 mg / day, it reduces productive symptoms (the actual antipsychotic effect).

Pharmacokinetics

After parenteral administration of 100 mg Cmax (2.2 mg / l) is determined after 30 minutes, after oral administration of 200 mg (0.73 mg / l) - after 4.5 hours. Bioavailability after oral administration is 25–35% (may vary significantly among individual patients). It easily penetrates into all organs, especially quickly into the liver and kidneys, more slowly into the brain tissue (the main amount is concentrated in the pituitary gland). Plasma protein binding - 40%. T1 / 2 is about 7 hours. Practically does not undergo biotransformation. Total Cl - 126 ml / min. Excretion occurs mainly by the kidneys (92% of the administered dose) by glomerular filtration and secretion; a small part (about 1% of the daily dose) is excreted in breast milk.

Special conditions

Be wary appoint patients with renal insufficiency, epilepsy, parkinsonism, the elderly and newborns; during work, drivers of vehicles and people whose profession is associated with increased concentration of attention.

Compound

• 1 ml 1 amp. Sulpiride 50 mg 100 mg Excipients: sulfuric acid, sodium chloride, water for injections.

Eglonil indications for use

• Acute and chronic psychoses (lethargy, delirium, confusion, agrammatism, abulia), schizophrenia; neurotic states accompanied by lethargy; psychosomatic symptoms (especially with peptic ulcer of the stomach and duodenum and hemorrhagic rectocolitis).

Eglonil contraindications

• Hypersensitivity, suspicion of pheochromocytoma.

Instruction

Tradename

Eglonil®

International non-proprietary name

Sulpiride

Dosage form

Capsules 50 mg

Compound

1 capsule contains

active substance- sulpiride 50 mg,

Excipients: lactose monohydrate, methylcellulose, talc, magnesium stearate,

composition of the capsule shell: gelatin, titanium dioxide (E171).

Description

Opaque white or off-white #4 hard gelatin capsules containing a creamy white powder.

Pharmacotherapeutic group

Antipsychotics. Psychotropic drugs. Benzamides

ATC code N05AL01

Pharmacological properties

Pharmacokinetics

After oral administration, the maximum plasma concentrations of sulpiride are reached after 3-6 hours, corresponding to 0.25 mg / l after taking 1 hard capsule of 50 mg. The bioavailability of oral dosage forms is 25-35% with high inter-individual variability. The pharmacokinetic profile of sulpiride remains linear after doses ranging from 50 to 300 mg. Sulpiride is rapidly distributed throughout the tissues of the body: the true volume of distribution in the saturation stage is 0.94 l / kg. Plasma protein binding is approximately 40%. Small amounts of sulpiride pass into breast milk, it crosses the placental barrier. In the human body, sulpiride undergoes poor metabolism. Sulpiride is excreted mainly through the kidneys, by glomerular filtration. The total clearance is 126 ml/min. The plasma half-life is 7 hours.

Pharmacodynamics

Eglonil® prevents dopaminergic nerve transmission in the brain tissues and has an activating effect, stimulating the dopaminomimetic effect. In high doses, Eglonil® also has an anti-productive effect. .

Indications for use

Short-term symptomatic treatment of anxiety disorders in adults when conventional therapies have failed

Severe behavioral disorders (agitation, self-mutilation, stereotypy) in children over the age of 6 years, especially in patients with autism syndromes.

Dosage and administration

For ingestion.

The lowest effective dose should always be used. If the patient's clinical condition allows, treatment should be started at a low dose, which can then be gradually increased.

adults

Short-term symptomatic treatment of anxiety conditions when conventional therapeutic measures are ineffective. The daily dose is 50 to 150 mg for no more than 4 weeks.

Children over 6 years old

Severe behavioral disorders (agitation, self-mutilation, stereotypy), especially in patients with autism syndromes. The daily dosage is 5 to 10 mg/kg. For children, dosing in the form of an oral solution is more acceptable.

Side effects

Early dyskinesia (spastic torticollis, oculogeric crises, trismus) reversible with anticholinergic antiparkinsonian drug

Extrapyramidal Syndrome:

Akinetic symptoms with or without hypertonicity, partially resolved with anticholinergic antiparkinsonian drugs

Hyperkinetic-hypertonic excitable motor activity

Akathisia

Tardive dyskinesia, characterized by involuntary rhythmic movements, mainly of the tongue and/or face, has been observed, as with other antipsychotics during long-term treatment: anticholinergic antiparkinsonian agents are ineffective and may provoke deterioration

Sedation or drowsiness

Convulsive seizures (see "Special Instructions")

Potentially fatal neuroleptic malignant syndrome (see "Special Instructions")

Transient hyperprolactinemia, reversible after discontinuation of treatment, likely causing amenorrhea, galactorrhea, gynecomastia, impotence, or frigidity

Weight gain

QT interval prolongation

Ventricular arrhythmias, such as torsades de pointes and ventricular tachycardia, which can lead to ventricular fibrillation and cardiac arrest

Sudden death (see "Special Instructions")

Postural hypotension

Cases of venous thromboembolism, including cases of pulmonary embolism and deep vein thrombosis, have been reported in connection with the use of antipsychotic drugs (see "Special Instructions")

Increased activity of liver enzymes

Maculopapular rash

Contraindications

Hypersensitivity to sulpiride or to one of the other components of the drug

Prolactin-dependent tumors (eg, pituitary prolactinomas and breast cancer)

Established or suspected pheochromocytoma

In combination with non-antiparkinsonian dopamine agonists (cabergoline and quinagolide) (see Drug Interactions)

Drug Interactions

Sedatives

It should be borne in mind that many drugs and substances can have an additional inhibitory effect on the central nervous system and contribute to a decrease in attention. These drugs include morphine derivatives (analgesics, antitussives and substitution therapies), antipsychotics, barbiturates, benzodiazepines, nonbenzodiazepine anxiolytics (such as meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramen), sedatives H1 antihistamines, centrally acting antihypertensives, baclofen and thalidomide.

Drugs that can cause pirouette tachycardia

This serious heart rhythm disorder can be caused by a number of drugs, antiarrhythmic and non-antiarrhythmic. Hypokalemia (see Potassium-lowering drugs) is a contributing factor, as is bradycardia (see Drugs that cause bradycardia) or pre-existing or acquired prolongation of the QT interval.

These drugs include, in particular, antiarrhythmic drugs of classes Ia and III and some antipsychotics.

As for erythromycin, spiramycin and vinkamycin, this interaction only applies to dosage forms for intravenous administration.

The simultaneous use of two torsadogenic drugs is usually contraindicated.

However, methadone, as well as some subclasses, are exceptions:

Antipsychotics that can cause torsades de pointes are also not recommended, but are not contraindicated in combination with other torsadogenic drugs.

Contraindicated combinations

(see section "Contraindications")

Non-antiparkinsonian dopamine agonists (carbegoline, quinagolide)

Mutual antagonism between dopamine agonists and antipsychotics.

(see "Special Instructions")

Increased risk of ventricular arrhythmias, in particular torsades de pointes.

If possible, treatment with an azole antifungal agent should be interrupted. If its use is unavoidable, the QT interval should be checked before treatment and further ECG monitoring should be carried out.

Antiparkinsonian dopamine agonists (amantadine,apomorphine, bromocriptine, entacapone, lisuride, pergolide, piribedil, pramipexole, ropinirole, selegiline)

Mutual antagonism between dopamine agonists and antipsychotics. If possible, treatment with an azole antifungal agent should be discontinued.

Dopamine agonists can cause or exacerbate psychotic disorders. If treatment with antipsychotics is necessary in patients with Parkinson's disease treated with dopamine agonists, the dose of these dopamine agonists should be reduced gradually (abrupt withdrawal puts the patient at risk of neuroleptic malignant syndrome).

Other drugs that can cause torsades de pointes:class Ia antiarrhythmics (quinidine, hydroquinidine, disopyramide) and class III (amiodarone, sotalol, dofetilide, ibutilide) and other drugs such as bepridil, cisapride, diphemanil, intravenous erythromycin, mizolastine, intravenous vincamine, moxifloxacin, intravenous spiramycin )

Other antipsychotics that can causepirouette tachycardia (amisulpride, chlorpromazine, cyamemazine, droperidol, haloperidol, levomepromazine, pimozide, pipothiazine, sertindole, sulpiride, sultopride, tiapride, veraliprid)

Increased risk of ventricular arrhythmias, in particular torsades de pointes.

Alcohol

Strengthening of the sedative effects caused by antipsychotic drugs.

Reduced alertness can make driving and operating machines dangerous. Patients should avoid drinking alcoholic beverages or taking medicines containing alcohol.

Levodopa

Mutual antagonism between levodopa and antipsychotics. Patients with Parkinson's disease should use the lowest effective dose of each of these drugs.

Methadone

Combinations requiring precautions for use

Beta-blockers for heart failure (bisoprolol, carvedilol, metoprolol, nebivolol)

Drugs that cause bradycardia (particularly class Ia antiarrhythmics, beta-blockers, some class III antiarrhythmics, some calcium channel blockers, digitalis glycosides, pilocarpine, anticholinesterases)

Increased risk of ventricular arrhythmias, especially torsades de pointes. Clinical monitoring and ECG monitoring is required.

Drugs that reduce the level of potassium in the blood (potassium-removing diuretics, alone or in combination, stimulant laxatives, glucocorticoids, tetracosactide and amphotericin B for intravenous administration)

Increased risk of ventricular arrhythmias, especially torsades de pointes.

Any hypokalemia should be corrected before administration of these agents, clinical monitoring, and electrolyte and ECG monitoring should be performed.

Sucralfate

Reduced gastrointestinal absorption of sucralfate and sulpiride. Observe the intervals between the use of sucralfate and sulpiride (more than 2 hours, if possible).

Gastrointestinal topicals, antacids and charcoal

Reduced gastrointestinal absorption of sulpiride. Intervals between the use of these agents and charcoal should be respected (greater than 2 hours if possible).

Combinations to consider

Antihypertensive agents

Beta blockers (excluding esmolol and sotalol and beta blockers used for heart failure)

Vasodilating effect and risk of hypotension, especially postural (additive effect).

Nitrates, nitrites and related agents

Increased risk of hypotension, particularly postural.

special instructions

Special precautions

Potentially fatal neuroleptic malignant syndrome: in case of hyperthermia of unknown origin, treatment should be discontinued without fail, as it may be one of the symptoms of a malignant neuroleptic syndrome described in connection with the use of antipsychotics (pallor, hyperthermia, autonomic dysfunction, impaired consciousness, muscle rigidity) .

Signs of autonomic dysfunction, such as increased sweating and changes in blood pressure, may precede hyperthermia and therefore be early warning signs.

Although this effect of antipsychotics may be idiosyncratic in origin, there may be predisposing factors such as dehydration and organic brain damage.

Prolonged QT interval: Sulpiride may cause a dose-dependent prolongation of the QT interval. This effect, which is known to increase the risk of developing serious ventricular arrhythmias, in particular torsades de pointes, is increased in patients with bradycardia, hypokalemia, and congenital or acquired QT prolongation (when sulpiride is taken with a drug that prolongs the QT interval) (see "Adverse actions").

Therefore, before using this drug, and if the clinical condition allows, the patient should be examined to identify the following risk factors that contribute to the development of this type of arrhythmia:

Bradycardia less than 55 bpm

hypokalemia

Congenital prolongation of the QT interval

Ongoing treatment with a drug that can cause severe bradycardia (less than 55 bpm), hypokalemia, intracardiac conduction delay, or prolongation of the QT interval (see sections "Contraindications" and "Drug Interactions")

brain stroke

In the treatment of elderly patients with dementia with atypical antipsychotics, there was an increased risk of stroke relative to placebo. The reason for this increased risk is unknown. An increased risk with other antipsychotics and in other patient populations cannot be ruled out.

This drug should be used with caution in patients with risk factors for stroke.

Elderly patients with dementia

The risk of mortality increases in elderly patients suffering from psychosis associated with dementia and being treated with antipsychotics.

The use of atypical antipsychotic drugs in patients compared with placebo increases the risk of mortality by 1.6-1.7 times.

After a median treatment period of 10 weeks, the risk of mortality in the treated group was 4.5% compared with 2.6% in the placebo group.

Most deaths were either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature.

Conventional antipsychotic drugs can increase mortality, as is the case with atypical antipsychotic drugs. The respective role of the antipsychotic agent and patient characteristics in increasing mortality is unclear.

Venous thromboembolism: cases of venous thromboembolism (VTE) have been reported in association with the use of antipsychotic drugs.

Due to the fact that patients treated with antipsychotics often have acquired risk factors for VTE, any possible risk factor for VTE should be identified before or during treatment with Eglonil and preventive measures should be taken (see section "Side Effects").

Consideration should be given to the risk of developing tardive dyskinesia even at low doses, particularly in elderly subjects.

Due to the fact that the efficacy and safety of sulpiride in children have not been fully studied, when using this drug, precautions should be observed (see "Method of application and doses"). An annual clinical evaluation is recommended to assess learning ability due to the cognitive effects of this drug. Dosing should be regularly adjusted based on the clinical condition of the child. Taking tablets and hard capsules is contraindicated in children under 6 years of age because the child may choke and this may lead to suffocation.

This medicinal product contains lactose and is therefore not recommended for patients with galactose intolerance, the Lapp lactase deficiency or galactose malabsorption syndrome (rare hereditary diseases).

Precautions for use

Patients with diabetes or risk factors for the development of diabetes who have begun treatment with sulpiride should conduct appropriate monitoring of blood glucose levels. Except in special cases, this medicinal product should not be used in patients with Parkinson's disease.

Patients with renal insufficiency need to reduce the dose and increase monitoring; in case of severe renal insufficiency, periodic courses of treatment are recommended.

Monitoring of treatment with sulpiride should be strengthened:

In the case of patients with epilepsy, since sulpiride may lower the convulsive threshold; cases of convulsive seizures have been reported in patients treated with sulpiride (see "Side Effects")

In the case of elderly patients with a greater tendency to postural hypotension, sedation and extrapyramidal effects.

Pregnancy and lactation

Good mental health of the mother is desirable to maintain throughout pregnancy to avoid decompensation. If drug therapy is necessary to ensure such a mental health condition, it should be initiated or continued at effective doses throughout the pregnancy. An analysis of exposures that occurred during pregnancy did not reveal any particular teratogenic effect of sulpiride. Injectable forms of antipsychotics used in emergency cases can cause hypotension in the mother.

Despite the fact that cases with newborns have not been described, theoretically sulpiride can cause the following symptoms if its use is continued until the end of pregnancy, especially at high doses:

Symptoms associated with its atropine-like effects, which are aggravated when combined with antiparkinsonian agents: tachycardia, irritability, abdominal distension, delayed meconium excretion

Extrapyramidal symptoms: hypertonicity, tremor

Sedation

Therefore, the use of Eglonil is possible at any stage of pregnancy. When monitoring newborns, the above effects should be taken into account.

Since sulpiride is excreted in breast milk, breastfeeding is not recommended during treatment.

Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

The attention of patients, especially those who drive a car or work with working mechanisms, should be paid to the possibility of drowsiness when using this drug (see section "Side Effects").

Overdose

Symptoms: Experience with cases of overdose of sulpiride is limited. Dyskinesia with spasmodic torticollis, tongue protrusion, and lockjaw are possible. Some patients may develop potentially life-threatening Parkinson's syndrome or even coma.

Treatment: Sulpiride is partially excreted by hemodialysis. There is no specific antidote for sulpiride. Symptomatic treatment, resuscitation with continuous careful monitoring of cardiac and respiratory functions (risk of prolongation of the QT interval and ventricular arrhythmias), which should be continued until the patient recovers. If severe extrapyramidal syndrome develops, an anticholinergic agent should be used.

Forms of release and packaging

15 capsules in a blister pack made of PVC film and aluminum foil.

2 blister packs, together with instructions for medical use in the state and Russian languages, are placed in a cardboard pack.

Storage conditions

Store at a temperature not exceeding 30o C.

Keep out of the reach of children!

Shelf life

Do not use after the expiration date.

Terms of dispensing from pharmacies

On prescription

Manufacturer/Packer

Sanofi Winthrop Industria, France

Location address: 6 boulevard de l'Europe, 21800 Quetigny, France

Registration certificate holder

Sanofi Aventis France, France

Address of the organization that accepts claims from consumers on the quality of products (goods) on the territory of the Republic of Kazakhstan

Sanofi-aventis Kazakhstan LLP

Republic of Kazakhstan, 050016, Almaty, st. Kunaeva 21B

phone: 8-727-244-50-96

fax: 8-727-258-25-96

e-mail: [email protected]

Attached files

484802871477977029_en.doc	97.5 kb
586476351477978204_kz.doc	125.5 kb

3D images

Composition and form of release

in a blister 10 pcs.; in a box of 3 blisters.

in a blister 12 pcs.; in a box 1 blister.

in a blister 6 ampoules; in a box 1 blister.

in glass bottles of 200 ml.

pharmachologic effect

pharmachologic effect- antipsychotic.

Blocks dopamine receptors.

Pharmacodynamics

In small doses, acting at the level of central dopaminergic receptors, it has a disinhibitory effect. In doses above 600 mg / day, it reduces productive symptoms (the actual antipsychotic effect).

Pharmacokinetics

After parenteral administration of 100 mg Cmax (2.2 mg / l) is determined after 30 minutes, after oral administration of 200 mg (0.73 mg / l) - after 4.5 hours. Bioavailability after oral administration is 25-35% ( may vary significantly among individual patients). It easily penetrates into all organs, especially quickly into the liver and kidneys, more slowly into the brain tissue (the main amount is concentrated in the pituitary gland). Plasma protein binding - 40%. T 1/2 is about 7 hours. Virtually no biotransformation. Total Cl - 126 ml / min. Excretion occurs mainly by the kidneys (92% of the administered dose) by glomerular filtration and secretion; a small part (about 1% of the daily dose) is excreted in breast milk.

Eglonil ® indications

Acute and chronic psychoses (lethargy, delirium, confusion, agrammatism, abulia), schizophrenia; neurotic states accompanied by lethargy; psychosomatic symptoms (especially with peptic ulcer of the stomach and duodenum and hemorrhagic rectocolitis).

Contraindications

Hypersensitivity, suspicion of pheochromocytoma.

Use during pregnancy and lactation

With prolonged use of high doses (over 200 mg / day), extrapyramidal syndrome was sometimes noted in newborns. Therefore, if necessary, treatment in pregnant and lactating women is recommended to lower the dose and reduce the duration of treatment.

Side effects

With prolonged use in high doses, lethargy, drowsiness, hyperprolactinemia, amenorrhea, galactorrhea, gynecomastia, impotence, frigidity, weight gain, early (spastic, torticollis, oculomotor disorders, spasm of masticatory muscles) and tardive dyskinesia, extrapyramidal disorders, orthostatic hypotension are sometimes possible , neuroleptic malignant syndrome (hyperthermia).

Interaction

Weakens the effect of levodopa, enhances the severity of lowering blood pressure against the background of antihypertensive drugs; incompatible with alcohol and other drugs that depress the central nervous system (mutual enhancement of sedative properties).

Dosage and administration

Psychoses: i/m- 200-800 mg / day for 2 weeks; inside- with negative symptoms - 200-600 mg / day, with productive symptoms - 800-1600 mg / day, with motor inhibition and psychosomatic disorders - 100-200 mg / day, with peptic ulcer of the stomach and duodenum - 150 mg / day for 4-6 weeks. Children (preferably in the form of a solution for oral administration) - 5-10 mg / kg / day (1 teaspoon - 25 mg; 4 drops - 1 mg).

Precautionary measures

Be wary appoint patients with renal insufficiency, epilepsy, parkinsonism, the elderly and newborns; during work, drivers of vehicles and people whose profession is associated with increased concentration of attention.

Storage conditions of the drug Eglonil ®

At a temperature not higher than 30 °C.

Keep out of the reach of children.

Expiration date of the drug Eglonil ®

3 years.

Do not use after the expiry date stated on the packaging.

Synonyms of nosological groups

Category ICD-10	Synonyms of diseases according to ICD-10
F20 Schizophrenia	Dementia praecox
	Bleuler's disease
	Sluggish schizophrenia
	Sluggish schizophrenia with apatoabulic disorders
	Exacerbation of schizophrenia
	Acute stage of schizophrenia with arousal
	Acute form of schizophrenia
	Acute schizophrenia
	Acute schizophrenic disorder
	Acute attack of schizophrenia
	Psychosis discordant
	Psychosis of the schizophrenic type
	Dementia early
	Febrile form of schizophrenia
	chronic schizophrenia
	Chronic schizophrenic disorder
	Cerebral organic insufficiency in schizophrenia
	Schizophrenic conditions
	Schizophrenic psychosis
	Schizophrenia
F22 Chronic delusional disorders	Delusional disorder, chronic
	delusional disorders
	delusional syndrome
	Paranoia
	Chronic affective-delusional states
F48 Other neurotic disorders	Neurosis
	Neurological diseases
	Neurotic disorders
	neurotic state
	Psychoneurosis
	Anxiety-neurotic states
	Chronic neurotic disorders
	Emotional Reactive Disorders
K25 Gastric ulcer	Helicobacter pylori
	Pain syndrome in gastric ulcer
	Inflammation of the stomach lining
	Inflammation of the gastrointestinal mucosa
	benign stomach ulcer
	Exacerbation of gastroduodenitis on the background of peptic ulcer
	Exacerbation of peptic ulcer
	Exacerbation of gastric ulcer
	Organic gastrointestinal disease
	Postoperative gastric ulcer
	Ulcer recurrence
	Symptomatic stomach ulcers
	Helicobacteriosis
	Chronic inflammatory disease of the upper gastrointestinal tract associated with Helicobacter pylori
	Erosive and ulcerative lesions of the stomach
	Erosive lesions of the stomach
	Erosion of the gastric mucosa
	peptic ulcer
	Stomach ulcer
	Ulcerative lesion of the stomach
	Ulcerative lesions of the stomach
K26 Duodenal ulcer	Pain syndrome in duodenal ulcer
	Pain syndrome in peptic ulcer of the stomach and duodenum
	Disease of the stomach and duodenum associated with Helicobacter pylori
	Exacerbation of peptic ulcer
	Exacerbation of duodenal ulcer
	Peptic ulcer of the stomach and duodenum
	Recurrent duodenal ulcer
	Symptomatic ulcers of the stomach and duodenum
	Helicobacteriosis
	Helicobacter pylori eradication
	Erosive and ulcerative lesions of the duodenum
	Erosive and ulcerative lesions of the duodenum associated with Helicobacter pylori
	Erosive lesions of the duodenum
	Peptic ulcer of the duodenum
	Ulcerative lesions of the duodenum
K51 Ulcerative colitis	Acute ulcerative colitis
	Colitis ulcerative hemorrhagic nonspecific
	Ulcerative trophic colitis
	ulcerative colitis
	Idiopathic ulcerative colitis
	Ulcerative colitis, nonspecific
	Nonspecific ulcerative colitis
	Ulcerative proctocolitis
	Purulent hemorrhagic rectocolitis
	Rectocolitis ulcerative-hemorrhagic
	Ulcerative necrotizing colitis
R41.0 Disorientation, unspecified	Disorientation
	Disturbance of consciousness
	Disturbance of consciousness of toxic origin
	Disturbance of consciousness of traumatic origin
	Orientation disorders
	Sopor
	State of disorientation
	Confusion
R46.4 Lethargy and retarded reaction	Anergy
	lethargy
	Ideation inhibition
	Motor retardation
	Psychomotor retardation
	Phenomena of ideomotor retardation

In this article, you can read the instructions for using the drug Eglonil. Reviews of site visitors - consumers of this medication, as well as opinions of doctors of specialists on the use of Eglonil in their practice are presented. A big request to actively add your reviews about the drug: did the medicine help or not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Analogues of Eglonil in the presence of existing structural analogues. Use to treat migraine and depression in adults, children, and pregnancy and lactation. The composition and interaction of the drug with alcohol.

Eglonil- an atypical antipsychotic from the group of substituted benzamides.

Sulpiride (the active substance of the drug Eglonil) has a moderate antipsychotic activity in combination with a stimulating and thymoanaleptic (antidepressive) effect.

The neuroleptic effect is associated with antidopaminergic action. In the central nervous system, sulpiride mainly blocks the dopaminergic receptors of the limbic system, and has little effect on the neostriatal system, it has an antipsychotic effect. The peripheral action of sulpiride is based on the inhibition of presynaptic receptors. An increase in the amount of dopamine in the central nervous system is associated with an improvement in mood, with a decrease in the development of symptoms of depression.

The antipsychotic effect of Eglonil is manifested in doses of more than 600 mg per day, in doses up to 600 mg per day, stimulating and antidepressant effects predominate.

Sulpiride has no significant effect on adrenergic, cholinergic, serotonin, histamine and GABA receptors.

In small doses, sulpiride can be used as an additional agent in the treatment of psychosomatic diseases, in particular, it is effective in stopping the negative mental symptoms of gastric and duodenal ulcers. In irritable bowel syndrome, sulpiride reduces the intensity of abdominal pain and leads to an improvement in the patient's clinical condition.

Low doses of sulpiride (50-300 mg per day) are effective for dizziness, regardless of etiology. Eglonil stimulates the secretion of prolactin and has a central antiemetic effect (inhibition of the vomiting center) due to the blockade of dopamine D2 receptors in the trigger zone of the vomiting center.

Compound

Sulpiride + excipients.

Pharmacokinetics

The bioavailability of dosage forms intended for oral administration is 25-35% and is characterized by significant individual variability. Sulpiride has a linear kinetics after doses ranging from 50 to 300 mg. Plasma protein binding is approximately 40%. Small amounts of sulpiride appear in breast milk and cross the placental barrier. In the human body, sulpiride is only slightly metabolized: 92% of the administered intramuscular dose is excreted in the urine unchanged. Sulpiride is excreted mainly through the kidneys, by glomerular filtration.

Indications

As monotherapy or in combination with other psychotropic drugs:

• acute and chronic schizophrenia;
• acute delirious states;
• depression of various etiologies;
• neurosis and anxiety in adult patients, with the ineffectiveness of conventional methods of treatment (only for 50 mg capsules);
• neurotic states accompanied by lethargy;
• psychosomatic symptoms (especially with peptic ulcer of the stomach and duodenum and hemorrhagic rectocolitis);
• severe behavioral disorders (agitation, self-mutilation, stereotypy) in children over the age of 6 years, especially in combination with autism syndromes (only for 50 mg capsules).

Release form

Capsules 50 mg.

Tablets 200 mg.

Solution for intramuscular injection (injections in ampoules for injection).

Oral solution (preferably for children) 0.5%.

Instructions for use and dosage

Pills

Acute and chronic schizophrenia, acute delirious psychosis, depression: the daily dose is from 200 to 1000 mg, divided into several doses.

Capsules

Neuroses and anxiety in adult patients: the daily dose is from 50 to 150 mg for a maximum of 4 weeks.

Severe behavioral disorders in children: the daily dose is 5 to 10 mg/kg body weight.

Solution for intramuscular injection (ampoules)

In acute and chronic psychosis, treatment begins with intramuscular injections at a dose of 400-800 mg per day and continues in most cases for 2 weeks. The goal of therapy is to achieve the lowest effective dose.

With intramuscular administration of sulpiride, the usual rules for intramuscular injections are observed: deep into the outer upper quadrant of the gluteal muscle, the skin is pre-treated with an antiseptic.

Depending on the clinical picture of the disease, intramuscular injections of sulpiride are prescribed 1-3 times a day, which allows you to quickly alleviate or stop the symptoms. As soon as the patient's condition allows, you should proceed to taking the drug inside. The course of treatment is determined by the doctor.

Tablets and capsules are taken 1-3 times a day with a small amount of liquid, regardless of the meal.

The goal of therapy is to achieve the lowest effective dose.

Doses for the elderly: the initial dose of sulpiride should be 1 / 4-1 / 2 doses for adults.

Side effect

• development of reversible hyperprolactinemia, the most common manifestations of which are galactorrhea, amenorrhea, menstrual irregularities;
• gynecomastia;
• impotence;
• frigidity;
• increased sweating;
• weight gain;
• sedative effect;
• drowsiness;
• dizziness;
• tremor;
• early dyskinesia (spastic torticollis, oculogeric crises, trismus), which resolves with the appointment of an anticholinergic antiparkinsonian agent;
• extrapyramidal syndrome and related disorders (akinesia, sometimes combined with muscle hypertonicity and partially eliminated by prescribing anticholinergic antiparkinsonian drugs, hyperkinesia-hypertonicity, motor agitation, akatsia);
• hyperthermia (increased body temperature);
• tachycardia;
• increase or decrease in blood pressure;
• in rare cases, orthostatic hypotension may develop;
• prolongation of the QT interval;
• very rare cases of development of the syndrome "torsade depointes";
• skin rash.

Contraindications

• prolactin-dependent tumors (eg, pituitary prolactinomas and breast cancer);
• hyperprolactinemia;
• acute intoxication with ethanol (alcohol), hypnotics, opioid analgesics;
• affective disorders, aggressive behavior, manic psychosis;
• pheochromocytoma;
• breastfeeding period;
• children's age up to 18 years (for tablets and solution for intramuscular injection);
• children's age up to 6 years (for capsules);
• in combination with sultopride, dopaminergic receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolid, ropinirole);
• hypersensitivity to sulpiride or another ingredient of the drug;
• due to the presence of lactose in the preparation, it is contraindicated in congenital galactosemia, glucose / galactose malabsorption syndrome or lactase deficiency.

Use during pregnancy and lactation

Animal experiments did not reveal teratogenic effects. In a small number of women who took low doses of Eglonil during pregnancy (approximately 200 mg per day), there was no teratogenic effect. There are no data on the use of higher doses of sulpiride. There is also no data on the potential effect of neuroleptic drugs taken during pregnancy on fetal brain development. Therefore, as a precautionary measure, it is preferable not to use sulpiride during pregnancy.

However, in the case of the use of this drug during pregnancy, it is recommended to limit the dose and duration of treatment as far as possible. In newborns whose mothers received long-term treatment with high doses of antipsychotics, gastrointestinal symptoms (bloating, etc.) associated with the atropine-like action of certain drugs (especially in combination with antiparkinson drugs), as well as extrapyramidal syndrome, were rarely observed.

With prolonged treatment of the mother, or when using high doses, as well as in the case of prescribing the drug shortly before childbirth, it is reasonable to monitor the activity of the nervous system of the newborn.

The drug passes into breast milk, so you should stop taking the drug during breastfeeding.

Use in children

Contraindicated in children under 18 years of age (for tablets and solution for intramuscular injection); children under 6 years of age (for capsules).

special instructions

Malignant neuroleptic syndrome: with the development of hyperthermia of undiagnosed origin, Eglonil should be discontinued, as this may be one of the signs of a malignant syndrome described with the use of neuroleptics (pallor, hyperthermia, autonomic dysfunction, impaired consciousness, muscle rigidity).

Signs of autonomic dysfunction, such as increased sweating and labile blood pressure, may precede the onset of hyperthermia and therefore represent early warning signs.

Although this action of antipsychotics may be idiosyncratic in origin, it appears that certain risk factors may predispose to it, such as dehydration or organic brain damage.

QT interval prolongation: Sulpiride prolongs the QT interval in a dose dependent manner. This action, which is known to increase the risk of developing serious ventricular arrhythmias such as "torsade de pointes", is more pronounced in the presence of bradycardia, hypokalemia, or congenital or acquired long QT interval (combination with a drug that causes prolongation of the QT interval).

• bradycardia with the number of beats less than 55 beats / min;
• hypokalemia;
• congenital prolongation of the QT interval;
• simultaneous treatment with a drug that can cause severe bradycardia (less than 55 beats / min), hypokalemia, slowing of intracardiac conduction or prolongation of the QT interval.

Except in cases of urgent intervention, patients who require treatment with antipsychotics are recommended to conduct an ECG during the status assessment.

Except in exceptional cases, this drug should not be used in patients suffering from Parkinson's disease.

In patients with impaired renal function, reduced doses should be used and monitoring should be strengthened; in severe forms of renal failure, intermittent courses of treatment are recommended.

Control during treatment with sulpiride should be strengthened:

• in patients with epilepsy, since the convulsive threshold may be lowered;
• in the treatment of elderly patients who are more sensitive to postural hypotension, sedation and extrapyramidal effects.

The consumption of alcohol or the use of medicines containing ethyl alcohol during treatment with the drug is strictly prohibited.

Influence on the ability to drive vehicles and control mechanisms

During treatment with Eglonil, it is forbidden to drive vehicles and work with mechanisms that require increased attention, as well as drinking alcohol.

drug interaction

Contraindicated combinations

Dopaminergic receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, kinagolid, ropinirole), except for patients suffering from Parkinson's disease: there is mutual antagonism between dopaminergic receptor agonists and antipsychotics. In extrapyramidal syndrome induced by antipsychotics, dopaminergic receptor agonists are not used; in such cases, anticholinergics are used.

Sultopride: increases the risk of ventricular arrhythmias, in particular atrial fibrillation.

Drugs that can cause ventricular arrhythmias such as "torsade de pointes": antiarrhythmics of class 1a (quinidine, hydroquinidine, disopyramide) and class 3 (amiodarone, sotalol, dofetilide, ibutilide), some antipsychotics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, amisulpride, tiapride, haloperidol, droperidol, pimozide) and other drugs such as: bepridil, cisapride, diphemanil, intravenous erythromycin, mizolastine, intravenous vincamine, etc.

Ethanol (alcohol): enhances the sedative effect of antipsychotics. Violation of attention creates a danger to driving vehicles and working on machines. The consumption of alcoholic beverages and the use of medicines containing ethyl alcohol should be avoided.

Levodopa: There is mutual antagonism between levodopa and antipsychotics. Patients with Parkinson's disease should be given the lowest effective dose of both drugs.

Dopaminergic receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, kinagolid, ropinirole) in patients with Parkinson's disease: there is mutual antagonism between dopaminergic receptor agonists and antipsychotics. The above drugs can cause or exacerbate psychosis. If treatment with a neuroleptic is necessary in a patient suffering from Parkinson's disease and receiving a dopaminergic antagonist, the dose of the latter should be gradually reduced until withdrawal (abrupt withdrawal of dopaminergic agonists can lead to the development of neuroleptic malignant syndrome).

Halofantrine, pentamidine, sparfloxacin, moxifloxacin: increased risk of ventricular arrhythmias, in particular "torsade de pointes". If possible, the antimicrobial drug that causes ventricular arrhythmia should be discontinued. If the combination cannot be avoided, the QT interval should first be checked and the ECG should be monitored.

Combinations requiring caution

Bradycardia-inducing drugs (calcium channel blockers with bradycardiac action: diltiazem, verapamil, beta-blockers, clonidine, guanfacine, digitalis alkaloids, cholinesterase inhibitors: donepezil, rivastigmine, tacrine, ambenonium chloride, galantamine, pyridostigmine, neostigmine): increased risk of ventricular arrhythmias , in particular "torsade de pointes". Clinical and ECG monitoring is recommended.

Drugs that reduce the level of potassium in the blood (potassium-releasing diuretics, stimulant laxatives, amphoteric B (intravenously), glucocorticoids, tetracosactide): the risk of ventricular arrhythmias increases, in particular "torsade de pointes". Before prescribing the drug, hypokalemia should be eliminated and clinical, cardiographic control, as well as control of electrolyte levels should be established.

Combinations to consider

Antihypertensive drugs: increased hypotensive effect and increased possibility of postural hypotension (additive effect).

Other CNS depressants: morphine derivatives (analgesics, antitussives and substitution therapy), barbiturates, benzodiazepines and other anxiolytics, hypnotics, sedative antidepressants, sedative histamine H1 receptor antagonists, centrally acting antihypertensives, baclofen, thalidomide - CNS depression, impaired attention creates danger to driving vehicles and working on machines.

Sucralfate, an antacid containing Mg and/or Al, reduces the bioavailability of oral dosage forms by 20-40%. Eglonil should be given 2 hours before taking them.

Eglonil's analogs

Structural analogues for the active substance:

• Betamax;
• Vero Sulpiride;
• Prosulpin;
• Sulpiride;
• Eglek.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.